EUROLAB
ep-511-biological-safety-leachables-toxicity-assessment
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

Comprehensive Guide to Eurolabs EP 5.1.1 Biological Safety Leachables Toxicity Assessment Laboratory Testing Service

Eurolabs EP 5.1.1 Biological Safety Leachables Toxicity Assessment laboratory testing service is governed by a range of international and national standards that ensure the accuracy, reliability, and safety of the test results.

  • ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories

  • ASTM F2475-13 (Reapproved 2020): Standard Test Method for Leachables Testing in Medical Devices

  • EN ISO 10993-17:2009: Biological evaluation of medical devices - Part 17: Tests for cytotoxicity in vitro

  • TSE L.R. No. 32/3: Turkish Standards Institution, Regulation on the Safety and Metrology Requirements of Medical Devices

    • These standards establish the requirements for laboratory testing, including:

  • Calibration and validation procedures

  • Quality control measures during testing

  • Data collection and recording procedures

  • Reporting standards and formats

  • Certification and accreditation aspects

  • Traceability and documentation requirements

    • Eurolabs expertise in this field ensures that our testing services meet or exceed these standards.

    The EP 5.1.1 Biological Safety Leachables Toxicity Assessment test is required to ensure the safety of medical devices, particularly those coming into contact with biological tissues. This includes:

  • Medical Devices Regulation (MDR) 2017/745: Article 10(2)(g), which requires manufacturers to conduct leachables testing

  • In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Article 11(3)(a), which requires manufacturers to perform biological safety testing, including leachables assessment

    • The consequences of not performing this test can be severe, including:

  • Device recalls and market withdrawals

  • Regulatory fines and penalties

  • Damage to brand reputation and customer trust

  • Inability to access international markets due to non-compliance with regulations

    • Eurolabs testing services help manufacturers meet these requirements and ensure the safety of their products.

    The EP 5.1.1 Biological Safety Leachables Toxicity Assessment test involves several steps:

  • Sample preparation: Preparing the medical device for leachables testing

  • Leachables extraction: Extracting potential leachables from the device using a suitable solvent

  • Chromatographic analysis: Separating and identifying the extracted compounds using high-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS)

  • Mass balance calculation: Calculating the mass of each compound leached from the device

  • Data interpretation: Interpreting the test results to determine the safety of the medical device

    • Eurolabs experienced technicians and state-of-the-art equipment ensure accurate and reliable results.

    The EP 5.1.1 Biological Safety Leachables Toxicity Assessment test report includes:

  • Summary: A summary of the test results, including any leached compounds detected

  • Table of contents: An outline of the reports contents

  • Introduction: Background information on the medical device and testing requirements

  • Methods: Details of the sample preparation, leachables extraction, and chromatographic analysis procedures

  • Results: Tabulated data showing the mass balance calculations and detected compounds

  • Discussion: Interpretation of the test results in relation to the safety of the medical device

    • Eurolabs reports are designed to be easy to understand and provide a clear picture of the testing results.

    The EP 5.1.1 Biological Safety Leachables Toxicity Assessment test provides numerous benefits, including:

  • Risk assessment: Identifying potential leachables and their safety implications

  • Quality assurance: Ensuring the medical device meets regulatory requirements

  • Compliance: Demonstrating compliance with relevant regulations and standards

  • Customer confidence: Building trust with customers by ensuring the safety of the product

  • International market access: Facilitating trade and export of medical devices to international markets

    • Eurolabs testing services help manufacturers meet these benefits and ensure the safety of their products.

    Eurolab is uniquely positioned to provide EP 5.1.1 Biological Safety Leachables Toxicity Assessment laboratory testing services due to:

  • Expertise: Experienced technicians with in-depth knowledge of the test methodology and regulatory requirements

  • State-of-the-art equipment: High-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS) instruments ensure accurate and reliable results

  • Accreditation: Eurolab is accredited to ISO/IEC 17025:2017, demonstrating our commitment to quality and competence

  • Customer service: Friendly and responsive customer support ensures a seamless testing experience

    • Choose Eurolab for your EP 5.1.1 Biological Safety Leachables Toxicity Assessment laboratory testing needs.

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    References

  • ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM F2475-13 (Reapproved 2020) - Standard Test Method for Leachables Testing in Medical Devices

  • EN ISO 10993-17:2009 - Biological evaluation of medical devices - Part 17: Tests for cytotoxicity in vitro

  • TSE L.R. No. 32/3 - Turkish Standards Institution, Regulation on the Safety and Metrology Requirements of Medical Devices

    • By choosing Eurolabs EP 5.1.1 Biological Safety Leachables Toxicity Assessment laboratory testing service, manufacturers can ensure the safety of their medical devices and comply with relevant regulations.

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    Additional Information

  • Test Turnaround Time: 5-7 business days

  • Sample Preparation: Eurolab will prepare samples according to the clients specifications

  • Chromatographic Analysis: HPLC or GC-MS analysis will be performed as necessary

    • For more information, please contact us at insert contact details. We look forward to assisting you with your EP 5.1.1 Biological Safety Leachables Toxicity Assessment testing needs.

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    Eurolab is committed to providing high-quality laboratory testing services that meet or exceed the requirements of regulatory bodies and industry standards.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

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